- Recalling firm
- International Life Sciences
- Reason for recall
- Augmentation devices failed bacterial endotoxin testing.
- Affected products (lot / model / serial)
- REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033
- Units affected
- N/A
- Distribution pattern
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
- Firm location
- Atlanta, GA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1555-2026
- Recall initiated
- February 6, 2026
- FDA classification date
- March 11, 2026
- FDA report date
- March 18, 2026
- FDA event ID
- 98399
- Last updated on HTM Vibe
- July 24, 2026